MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1011707-28

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Stenosis (2263)

Event Date 02/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.The reported patient effects of angina and stenosis are listed in the xience prime, xience prime small vessel (sv), and xience prime long length (ll) everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The xience prime 2.5 x 23 referenced in the report is being filed under a separate medwatch report number.

Event Description

It was reported that on (b)(6) 2014, the patient underwent a coronary stenting procedure with implantation of a 3.0 x 38 mm xience prime stent in the proximal left anterior descending artery, a 2.5 x 23 mm xience prime stent in the first obtuse marginal artery and a 2.5 x 28 mm xience prime stent in the distal circumflex artery.On (b)(6) 2015, the patient began to experience angina and was re-hospitalized on (b)(6) 2015.A revascularization procedure was performed, on (b)(6) 2015, to treat in-stent restenosis at the distal circumflex artery, within 5 mm of the previously implanted stent and the event resolved on (b)(6) 2015.On (b)(6) 2016, the patient began to experience angina and was re-hospitalized on (b)(6) 2016.Revascularization was performed on (b)(6) 2016 to treat in-stent restenosis at the 1st obtuse marginal artery, within 5 mm of the previously implanted stent and the event resolved on (b)(6) 2016.On (b)(6) 2016, the patient began to experience angina and was rehospitalized on (b)(6) 2016.A revascularization procedure was performed, with stent implantation at the 1st obtuse marginal artery, within 5 mm of the previously implanted stent.The event resolved on (b)(6) 2016.No additional information was provided.

• Brand Name: XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6201000
• MDR Text Key: 63185015
• Report Number: 2024168-2016-09189
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648123481
• UDI-Public: (01)08717648123481(17)150509(10)3053141
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2015
• Device Catalogue Number: 1011707-28
• Device Lot Number: 3053141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STENT: 3.0X38 XIENCE PRIME, 2.5X23 XIENCE PRIME; STENT: 3.0X38 XIENCE PRIME, 2.5X23 XIENCE PRIME; STENT: 3.0X38 XIENCE PRIME, 2.5X23 XIENCE PRIME
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR